Quality Validation Engineer 845
Gemma Hayes Recruitment
2 months ago
Manufacturing / Engineering
On Application

Visa Compliance
Due to the urgency of this vacancy, our client is unable to go down the route of work permits, visas or sponsorship.
It is therefore ESSENTIAL that all candidates have FULL AUTHORITY to work in Ireland.

Position Summary
The successful applicant will Generate applicable documentation to Automated Equipment Validation of Quality Management System.

Key Responsibilities and End Results
* Generate applicable documentation to Automated Equipment Validation of Quality Management System.
* Write the necessary validation protocols, & amendments of the Quality Management System ensuring compliance with the latest FDA directives / requirements within the Medical Device Sector.
* Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
* Development of validation projects.
* Support the implementation of Company Policies and GMP.
* Support all company safety and quality programs and initiatives.
* Experience in working with Automation Vendors.
* Ensure ongoing compliance with GMP in all practices, recording of events and processes.
* Ensure compliance with all learnings from all GMP training events.
* Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

Job Specifications
* Degree in Engineering/Science discipline.
* 3 to 5 years’ experience in a Validation Quality Engineering role.
* Strong working knowledge of Validation Process. Experience in method validation and process characterization an advantage.
* Strong working knowledge in the application of quality engineering tools and techniques with key emphasis on GAMP5 and Master Validation Planning.
* Excellent organisation, communication, computer, & presentation skills.
* Excellent initiative, decision-making and be able to work in a core team environment attaining resolutions.

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